Actively Recruiting

Phase 2
Age: 18Years - 55Years
All Genders
Healthy Volunteers
NCT07207408

Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

Led by Dynavax Technologies Corporation · Updated on 2025-10-06

148

Participants Needed

3

Research Sites

57 weeks

Total Duration

On this page

Sponsors

D

Dynavax Technologies Corporation

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study will evaluate the immunogenicity, safety, and tolerability of rF1V-1018 vaccine

CONDITIONS

Official Title

Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age

Who Can Participate

Age: 18Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 to 55 years of age
  • Healthy or with stable pre-existing medical conditions without major medication changes or hospital visits in past 3 months
  • Able to follow study schedule and procedures
  • Able and willing to provide written informed consent
  • If female and able to have children, must use effective contraception for 28 days before vaccination, have negative pregnancy tests before vaccination, and continue contraception for 3 months after last dose
  • Women not of childbearing potential include those with documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation
Not Eligible

You will not qualify if you...

  • History of plague disease or previous plague vaccine
  • Active tuberculosis or other systemic infections
  • History or positive test for HIV, hepatitis B, or hepatitis C
  • History of autoimmune disorders
  • Sensitivity to any vaccine components
  • Body mass index 30 kg/m2 or higher
  • Recent use of certain vaccines or immune-modifying drugs within specific timeframes before trial injections
  • Pregnant, breastfeeding, or planning pregnancy
  • Undergoing or expected to undergo chemotherapy or recent cancer diagnosis except certain skin cancers
  • Any condition or treatment that could interfere with trial participation or results
  • Fever of 386C (100.46F) or higher at vaccination
  • History of heart attack or coronary artery disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

AMR- Miami

Miami, Florida, United States, 33134

Not Yet Recruiting

2

AMR- El Dorado

El Dorado, Kansas, United States, 67042

Actively Recruiting

3

AMR- Las Vegas

Las Vegas, Nevada, United States, 889119

Actively Recruiting

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Research Team

O

Ouzama Henry, MD, Vice President, Clinical Development

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

6

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Immunogenicity, Safety, and Tolerability of rF1V-1018 Vaccine in Adults 18 to 55 Years of Age | DecenTrialz